What responsible supplement companies need to know
On December 15, 2010, FDA announced that it is working with U.S. trade associations, including the American Herbal Products Association (AHPA), to make sure that supplement companies comply with the law. FDA also issued a letter to industry that addresses roles and responsibilities of companies to ensure that their products do not contain undeclared ingredients that would cause them to be adulterated. More specifically, FDA’s letter:
- Reminds dietary supplement companies of their obligation under current good manufacturing practice (cGMP) to establish and meet specifications on those types of contamination that may adulterate or lead to adulteration of the finished batch of dietary supplement (see 21 CFR 111.70(b) and 111.75(a))
- Notes that a strong program of qualifying suppliers, testing incoming ingredients, and verifying the contents of finished products are all required by cGMP regulations and can help minimize the risk of adulteration
- Encourages companies to report any suspected ingredients or finished products and the manufacturers or distributors who market these products to FDA. Reports can be submitted via email to TaintedProducts@fda.hhs.gov or via FDA’s anonymous reporting form “Report Suspected Criminal Activity” located at: http://www.fda.gov/oci
AHPA has publicly expressed its support for FDA actions against marketers of products that masquerade as dietary supplements but contain illegal ingredients. AHPA encourages FDA to use its regulatory authority to hold accountable those who violate the law and jeopardize the public confidence, including all legal means to enforce the law.
Manufacturers and marketers may contact AHPA with any questions you may have on your manufacturing and labeling obligations.